Manufacturing Associate, Upstream

BioTalent; Tustin (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

BioTalent partners with a leading clinical and commercial biologics CDMO to support cGMP upstream bioprocessing. The Manufacturing Associate, Upstream will support mammalian cell culture operations, operate 100L–2000L bioreactors, and participate in cleaning, sterilization, and aseptic filling activities.

Responsibilities include running current processes, maintaining cultures, performing harvests, and ensuring compliant documentation.

Qualifications

• Bachelor's degree in a relevant field and 1+ years in a related role.
• Experience in cGMP manufacturing environments and aseptic techniques.
• Familiarity with mammalian cell culture operations is preferred.

Responsibilities

• Perform cGMP upstream manufacturing activities in a multi-product facility.
• Operate and maintain mammalian cell culture bioreactors (Wave and single-use systems 100L–2000L).
• Execute cell culture expansions and maintain cultures aseptically.
• Monitor, operate, and troubleshoot manufacturing equipment and process systems.
• Perform harvest operations including filtration and TFF processes.
• Prepare media and buffers to support operations.
• Complete cGMP documentation (batch records, SOPs, forms, deviations).
• Collaborate with cross-functional teams for production, maintenance, validation, and tech transfer.
• Assist with investigations, audits, inspections, and continuous improvement initiatives.
• Perform aseptic filling and contribute to quality release.

Skills

Mammalian cell culture

cGMP manufacturing

Aseptic techniques

Education

Bachelor's degree in Chemical Engineering/Biochemical Engineering/Biology

Tools

Wave bioreactor

Single-use systems

Job description

We are partnering with a leading clinical and commercial biologics CDMO focused on developing and manufacturing biopharmaceuticals. They are seeking a Manufacturing Associate, Upstream to support cGMP cell culture manufacturing operations in a multi-product environment. This role offers the opportunity to work with mammalian cell culture, bioreactor operations, aseptic processing, and upstream manufacturing activities that support the production of high-quality biologic products.

Key Responsibilities

• Perform cGMP upstream manufacturing activities in a multi-product biopharmaceutical facility.
• Operate and maintain mammalian cell culture bioreactors, including Wave and single-use systems ranging from 100L to 2000L.
• Execute cell culture expansion activities and maintain mammalian cell cultures using aseptic techniques.
• Monitor, operate, and troubleshoot manufacturing equipment and process systems.
• Perform harvest operations, including filtration and TFF processes.
• Prepare media and buffers to support manufacturing operations.
• Complete cGMP documentation, including batch records, SOPs, forms, and deviation reporting.
• Collaborate with cross-functional teams to support production, maintenance, validation, and technology transfer activities.
• Assist with investigations, audits, inspections, and continuous improvement initiatives.
• Perform aseptic filling and help ensure the timely release of quality products.

Qualifications & Requirements

• Bachelor's degree with 1+ years of relevant experience in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, or a related field.
• Experience working in cGMP manufacturing environments and utilizing aseptic techniques.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.